[Updates: MNTA loses Lovenox patent case; 2017-2018 news flow; rationale for M281; transcript of 2Q17 CC; 6/30/17 pro forma cash balance = $464M; diluted share count for valuation purposes.]
CORPORATE AND FINANCIAL
What is MNTA’s business all about? #msg-119915120MNTA’s drug portfolio and pipeline #msg-1335174882017-2018 news flow #msg-133532612 Transcript of 2Q17 conference call (8/2/17) #msg-130999575 Reasons to be optimistic #msg-26837144Momenta’s mantra on interchangeable FoBs #msg-130220988 Incoming FDA commissioner emphasizes interchangeable FoBs #msg-25803923The Pink Sheet interviews Craig Wheeler (dated, but still a good read)
Valuation and finances #msg-133589207MNTA had $464M pro forma cash at 6/30/17 #msg-133589478 Diluted share count for valuation purposes #msg-133492994 2Q17 press release
Economic rationale and profit split #msg-12222305 NVS/MNTA split Glatopa profits 50/50 #msg-113300123 MNTA guides to $35K revenue per Glatopa patient-year
40mg Glatopa #msg-128816545Compliance issue at PFE plant delays approval of 40mg Glatopa #msg-129066912 Text of PFE’s warning letter from FDA #msg-124820193“At risk” launch likely upon FDA approval
#msg-129439764Teva loses patent trial on 40mg-Copaxone patents #msg-125465255 Issue in 40mg patent litigation was (and is) obviousness
20mg Glatopa #msg-112799454 FDA approves 20mg Glatopa #msg-112799896 FDA’s rationale for approval of 20mg Glatopa
Potential competition from other generic-Copaxone products #msg-124749893Handicapping the competitive landscape for 40mg Copaxone #msg-132347810Mylan receives CRL for generic Copaxone #msg-90636221 Mylan and MNTA products are not identical #msg-129230239 More discussion on Mylan’s (20mg and 40mg) ANDAs #msg-129225380 RDY, Biocon not close to FDA approval for either 20mg or 40mg #msg-115896634 PFE licenses Synthon’s Copaxone ANDA #msg-70039774 Synthon submits Copaxone ANDA… #msg-99675480 …but acknowledges receiving CRL
#msg-59682546MNTA’s ‘187 patent may thwart other generics (1) #msg-112887376 H-W Safe Harbor probably doesn’t apply to MNTA’s ‘187 patent
FOLLOW-ON BIOLOGICS (FoB) PROGRAM
FDA guidance and MNTA’s view on interchangeable FoBs #msg-127909952FDA issues (draft) guidance on interchangeable FoBs #msg-130220988 Incoming FDA commissioner emphasizes interchangeable FoBs… #msg-26837144 …which fits right in with Momenta’s mantra on interchangeable FoBs #msg-127947222 FDA permits indication extrapolation for interchangeable FoBs
M923 (Humira FoB) program #msg-125412687MNTA regains full ownership of M923… #msg-127579499 …while monetizing Shire’s contractual obligations to the program #msg-130582027Interchangeable Humira FoB for US is badly needed… #msg-127962983 …and has colossal upside for MNTA
#msg-126858164Positive phase-3 data for M923 #msg-127945401 Phase-3 trial of M923 included switching to/from branded Humira (1) #msg-130182027 Phase-3 trial of M923 meets FDA draft guidelines for interchangeable FoBs
#msg-118781959Can Abbvie block US Humira FoBs until 2022? #msg-126869318 Abbvie’s Humira-formulation patents not an impediment, says CW #msg-131412374 ABBV’s ‘135 Humira-dosing patent invalidated (actual ruling) #msg-131412917 ABBV’s ‘135 Humira-dosing patent invalidated (what it means) #msg-129261201 UK Court rejects Humira “method of use” patents
#msg-125359509 FDA approves Amgen’s Humira FoB (Amjevita) #msg-126114458 Amgen not launching Humira FoB until 2018 (or later) due to IP
MNTA/Mylan partnership for Orencia and 5 other FoBs #msg-119689602MNTA inks 50/50 partnership with Mylan for 6 FoBs #msg-119697433 Commentary on MNTA-Mylan partnership by FierceBiotech
#msg-126247535MNTA/Mylan start phase-1 trial of Orencia FoB #msg-129440984 Orencia has annualized global sales of $2.5B #msg-128079578 Speculation re identities of other 5 FoBs in partnership #msg-128904877 Why Avastin is not one of the FoBs in the partnership
Miscellaneous FoB info #msg-123094763 FDA’s FoB guidance docs (other than for interchangeable status) #msg-48581353 Text of BPCIA enabling US FoBs #msg-70191760 US patent-expiration dates of big-selling biologics
PROPRIETARY AUTOIMMUNE PROGRAM
#msg-107107809Structure/rationale of M281, M230, and M254 (slides 118-142)
#msg-127656306MNTA inks M230/autoimmune collaboration with CSL #msg-127780821 CSL collaboration has dual opt-on options for MNTA #msg-129436390 MNTA introduces M230 (press release) #msg-128995744Biocentury Innovations write-up on M230
#msg-126849411 Recent patent applications and overview of IP estate #msg-59682546 USPTO issues ‘187 patent re Copaxone manufacturing #msg-89344512 USPTO issues sialylation patent licensed to MNTA